Perioperative Intravenous Administration of High Volume Lactated Ringers Solution and the Risk of post-ERCP Pancreatitis
Aims: Pancreatitis (inflammation of the pancreas) is the most frequent serious complication of endoscopic retrograde cholangiopancreatography (ERCP) resulting in prolonged hospitalizations and in rare cases, death. ERCP is a procedure where  a long tube is inserted down the esophagus, through the stomach, and into the duodenum (small intestine). ERCP procedures are typically used to treat problems of the pancreas or bile ducts that can cause abdominal pain and elevated enzymes. The purpose of the study is to examine whether giving large amounts (2 – 3 liters) of intravenous (IV) fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis (PEP). Typically, a small amount of IV fluids are given during this procedure (approximately 1 liter). It is believed that the administration of increased fluids will allow circulation within the pancreas to continue during the procedure, thus decreasing the risk of injury and subsequent inflammation. 
Diagnosis:
Pancreatitis
Principal Investigator:
Mick S. Meiselman, MD
IRB Approval Number:
EH 13-130
Sponsor:
 NorthShore University HealthSystem
Contact:
 Interested patients should contact study coordinator Asantewaa Ture at 847.570.3708
Open to Enrollment:
Yes

The role of genotypic clarithromycin resistance testing using PCR detection of 23S mutations in predicting failure of eradication of Helicobacter pylori infection with standardized clarithromycin proton pump inhibitor (PPI) based triple therapy
Aims: Helicobacter pylori (H. pylori) is a bacterium that infects the stomach and can cause peptic ulcers and stomach cancer.  Normally, H. pylori is tested for using a CLO test, a urease breath test, a stool antigen test, or tissue biopsy. In addition, the treatment for the bacteria typically consists of clarithromycin triple therapy. There is data that suggests the clarithromycin triple therapy may not cure H. pylori infections in up to 30% of cases in the United States. Therefore, the purpose of this study is to determine whether molecular tests done on H. pylori bacteria taken from stomach tissue can predict clarithromycin treatment failure. H. pylori can have genes that make it resistant to specific drugs. By testing stomach tissues (taken during an esophagogastroduodenoscopy or EGD), we will be able to determine whether H. pylori will respond to certain types of drugs. 
Diagnosis:
H. pylori Infection
Principal Investigator:
Karen Kaul, MD, PhD
Other Investigator: Jay Goldstein, MD and Dena Shibib, DO
IRB Approval Number:
EH 13-101
Sponsor:
 NorthShore University HealthSystem Department of Medicine and Department of Pathology
Contact:
 Interested patients should contact Boris Jancan, CCRP at 847.570.1583
Open to Enrollment:
Yes

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study of the Efficacy and Safety of ALV003 Treatment in Symptomatic Celiac Disease Patients Maintained on a Gluten-Free Diet
Aims: Celiac disease is an inherited, life-long disease affecting children and adults. There is no drug treatment or cure for celiac disease. When people with celiac disease eat gluten (a plant protein found in foods like wheat, rye, barley, and many everyday products), there is a reaction that damages their small intestine and interferes with the ability of their intestine to take in nutrients.  ALV003 is an investigational drug under development by Alvine Pharmaceuticals that can break down gluten into smaller pieces of protein. The smaller protein fragments are expected to be less damaging to the small intestine. The purpose of the study is to determine whether ALV003 is able to improve the damage in the lining of the intestine caused by gluten. In addition, the study will determine whether ALV0003 improves any of the symptoms related to celiac disease.    
Diagnosis:
Celiac Disease
Principal Investigator:
Jay Goldstein, MD
Other Investigators: David Labowitz, DO and Eugene Yen, MD
IRB Approval Number:
EH13-212
Sponsor:
 Alvine Pharmaceuticals, Incorporated
Contact:
Interested patients should contact study coordinator Asantewaa Ture at 847.570.3708
Open to Enrollment:
 Yes

A Randomized, 12-week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patient with Chronic Idiopathic Constipation
Aims: This study will evaluate the efficacy and safety of 3.0 mg and 6.0 mg plecanatide versus placebo in patients with chronic idiopathic constipation. Participants will be given rescue medication (Ducolax), but will have restrictions on how often the rescue medication can be used. Plecanatide causes increased fluid secretion within the colon. The fluid secretion is expected to facilitate bowel movements.
Diagnosis: Chronic Idiopathic Constipation
Principal Investigator
: Jay Goldstein, MD
Other Investigators:
Eugene Yen, MD, Laura Bianchi, MD, and David Labowitz, DO
IRB Approval Number: EH 14-041
Sponsor: Synergy Pharmaceuticals
Contact: Interested patients should contactstudy coordinator Asantewaa Ture at 847.570.3708
Open to Enrollment:
Yes

Fecal Microbiota Transplantation (FMT) / Stool Transplant
Aims: C. difficile is not only occurring more frequently, but there is also an epidemic of serious cases which are refractory to therapy and have high rates of colectomy and death. The use of antimicrobials may predispose patients to further relapses by disturbing intestinal flora and can contribute to the problem of drug resistance. FMT has been shown to restore phylogenetic richness and diversity of the intestinal microbiome thereby restoring colonization resistance. Dr. Yen and several Infectious Disease physicians oversee screening and scheduling patients who may qualify to receive a stool transplant.
Diagnosis: C. difficile infection 
Principal Investigator
: Eugene Yen, MD
Other Investigators:
Becky Smith, MD, Leonard Kaplan, MD, Stephen Schrantz, MD, Jeffery Semel, MD, Shailesh Bajaj, MD, David Labowitz, DO, and Todd Nega, MD
IRB Approval Number: EH 13-450
Sponsor: NorthShore University HealthSystem
Contact: Interested patients should contactstudy coordinator Asantewaa Ture at 847.570.3708
Open to Enrollment:
Yes

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